Effects of Sustained-release Oral Sodium Nitrite Supplementation on Pain-related Outcomes and Peri- and Postoperative Physiology in People Undergoing Unilateral All-component Revision Total Knee Arthroplasty

This study will determine whether a drug called sodium nitrite helps improve pain and post-operative recovery associated with knee replacement surgery.

Start Date01 Nov 2024

Sponsor / Collaborator

The University of Alabama at Birmingham

NCT05798481 / RecruitingEarly Phase 1IIT

A Pilot Pre-Phase 1 Clinical Trial to Study How Administering Sublingual Nitric Oxide Donor S-nitroso-N-acetylcysteine Affects the Systemic Blood Pressure in Healthy Human Volunteers.

The purpose of the study is to increase the in vivo levels of nitric oxide by generating nitric oxide donor compound S-nitrosoacetylcysteine (SNOAC) using the mixture of sodium nitrite and N-acetylcysteine crystals in the sublingual space. The generated SNOAC rapidly diffuses into blood circulation thereby decrease the systemic blood pressure. This compound can be an alternative to organic nitrate NO donor drugs without developing tolerance in patients.

Start Date01 Mar 2024

Sponsor / Collaborator

The University of Alabama at Birmingham

ACTRN12622001330730 / RecruitingPhase 1/2IIT

Elucidating the effects of nebulized sodium nitrite and argon on blood pressure and cerebrovascular haemodynamics in healthy adults and hypertensive patients

Start Date09 Jan 2023

Sponsor / Collaborator

Auckland University

100 Clinical Results associated with Sodium nitrite

100 Translational Medicine associated with Sodium nitrite

100 Patents (Medical) associated with Sodium nitrite

1,308

Literatures (Medical) associated with Sodium nitrite

01 Jan 2025·MEAT SCIENCE

Reduction of N-nitrosamine in cured ham using atmospheric cold plasma-treated cauliflower powder

Article

Author: Jeon, Hayeon ; Jo, Kyung ; Lee, Seonmin ; Yang, Han-Sul ; Eom, Jeong-Uk ; Jung, Samooel ; Jeong, Seul-Ki-Chan

The effects of cauliflower treated with atmospheric cold plasma (ACP), as a natural nitrite source, on the curing of ground ham and nitrosamine formation were investigated. Ground ham was prepared using sodium nitrite and ACP-treated cauliflower powder (PTCP) to achieve initial nitrite concentrations of 60 and 100 mg/kg, respectively. ACP treatment generated nitrite in cauliflower but significantly reduced the antioxidant activity (P < 0.05). As a nitrite source, PTCP had similar effects as sodium nitrite in the development of cured color in ground ham, with a comparable residual nitrite content (P ≥ 0.05). Three nitrosamines, N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA), and N-nitrosopyrrolidine (NPYR), were detected in ground ham. NPYR formation was significantly lower in ground ham treated with PTCP at an initial nitrite concentration of 100 mg/kg (P < 0.05). Therefore, the use of a natural nitrite source manufactured through ACP treatment can prospectively achieve suitable curing efficiency while simultaneously suppressing nitrosamine formation.

31 Dec 2024·Future Science OA

Fischer's oligopeptide ratio in ischemic hypoxia: prophylactic amendment of sophoretin and melatonin supplementation

Article

Author: Ali, Hanaa Mahmoud ; O Kadry, Mai

Aim: The fundamental pathophysiology of ischemic-hypoxia is oxygen depletion. Fischer's ratio is essential for monitoring hypoxia intensity. Methods: the current study highlighted the prophylactic role of sophoretin (QRC) and/or melatonin (MLN) versus sodium nitrite (SN) brain hypoxia. Results: Prophylactic treatment with sophoretin and MLN, was preceded with hypoxia-induction via sodium nitrite (60 mg/kg, S.C.). SN decreased hemoglobin (Hb), elevated HIF-α, HSP-70, IL-6 and TNF-α. Sophoretin and/or MLN restored the ameliorated inflammatory biomarkers, modulated norepinephrine, dopamine, serotonin and gamma-aminobutyric acid (GABA). Similarly, single-cell gel electrophoresis (SCGE or COMET) DNA damage assay confirmed this finding. Conclusion: Treatment via sophoretin and MLN was the most effective therapy for improving sodium nitrite-induced brain injury.

01 Nov 2024·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Application of bacterial nanocellulose film loaded with sodium nitrite, sumac, and black carrot extracts to reduce sodium nitrite, extend shelf life, and inhibit Clostridium perfringens in cooked beef ham

Article

Author: Aliakbarlu, Javad ; Shiravani, Zolaikha ; Moradi, Mehran

This study aimed to develop innovative bacterial nanocellulose (BNC) films incorporated with sodium nitrite (SN), sumac extract (SE), and black carrot extract (BCE) to reduce sodium nitrite, extend shelf life, and inhibit Clostridium perfringens in cooked beef ham. The ham covered with BNC film immersed in SE (10 % w/v) + BCE (5 % w/v) + SN (125 ppm) (SE₁₀BCE₅SN₁₂₅) exhibited the lowest microbial load (4.39, 4.32, 3.83, and 4.6 log cycles reductions in total viable count, lactic acid bacteria, Enterobacteriaceae, and C. perfringens, respectively) and the lowest oxidation rate (70 % reduction compared to control) on day 28 of storage. The samples covered with SE₁₀BCE₅SN₁₂₅ film had also the lowest level of residual nitrite (64 % lower compered to positive control). Positive control (ham containing 120 ppm SN) and ham covered with SE₁₀BCE₅SN₁₂₅ film had the highest redness. It was concluded that the films developed in this study have the potential to reduce the use of sodium nitrite in beef ham production.

News (Medical) associated with Sodium nitrite

01 Feb 2024

·www.biospace.com

FDA Issues Reminder of Non-Substitution of PEDMARK® (sodium thiosulfate injection) for Pediatric Patients Receiving Cisplatin

RESEARCH TRIANGLE PARK, N.C., Feb. 01, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a public reminder to healthcare providers that PEDMARK (sodium thiosulfate injection) is not substitutable with other sodium thiosulfate products as explicitly directed in its prescribing label. PEDMARK is the first and only FDA approved therapy indicated to reduce the risk of ototoxicity (e.g., permanent hearing loss) associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. The FDA stated in the public communication that it is aware that some providers may be preparing other sodium thiosulfate (STS) products for patient use in place of PEDMARK, including diluting STS products approved for other uses to match the strength of PEDMARK. The FDA reminded health care providers that as stated in PEDMARK’s prescribing information, PEDMARK is not substitutable with other sodium thiosulfate products. The FDA stated that such substitutions pose potential health risks, including: Potassium chloride exposure which, at high doses, can lead to increased risk of acute cardiac events and other serious adverse reactions. Potassium chloride is not present in PEDMARK. Overexposure to boric acid (a boron compound), can cause health risks including headache, hypothermia, restlessness, weariness, renal injury, dermatitis, alopecia, anorexia and indigestion. Although PEDMARK also contains boric acid, it is at a lower concentration than other STS products. Overexposure to sodium nitrite, which can lead to health risks including methemoglobinemia. Sodium nitrite is co-packaged with sodium thiosulfate as a separate vial in some products; it is not present in PEDMARK. The public communication was issued by the FDA’s Professional Affairs and Stakeholder Engagement Staff within the Center for Drug Evaluation and Research, Office of Communications. The FDA encourages those with any questions to contact FDAOncology@fda.hhs.gov. About Fennec Pharmaceuticals Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development and commercialization of PEDMARK® and Pedmarqsi to reduce the risk of platinum-induced ototoxicity in pediatric patients. Further, PEDMARK received FDA approval in September 2022 and European Commission Marketing Authorization in June 2023 for Pedmarqsi. PEDMARK has received Orphan Drug Exclusivity in the U.S. for seven years of market protection and Pedmarqsi has received Pediatric Use Marketing Authorization in Europe which includes eight years plus two years of data and market protection. Fennec has a license agreement with Oregon Health and Science University (OHSU) for exclusive worldwide license rights to intellectual property directed to sodium thiosulfate and its use for chemoprotection, including the reduction of risk of ototoxicity induced by platinum chemotherapy, in humans. For more information, please visit . Investors: Robert Andrade Chief Financial Officer Fennec Pharmaceuticals Inc. +1 919-246-5299 Corporate and Media: Lindsay Rocco Elixir Health Public Relations +1 862-596-1304 lrocco@elixirhealthpr.com

Orphan DrugLicense out/inDrug Approval

31 Aug 2023

·www.biospace.com

JanOne to Present In Person and by Video at H.C. Wainwright's 25th Annual Global Investment Conference

Chief Medical Officer Dr. Amol Soin will discuss innovative approaches to pain management and JanOne's development of non-addicting treatments for pain LAS VEGAS, Aug. 31, 2023 /PRNewswire/ -- JanOne (Nasdaq: JAN), the biopharmaceutical company focused on developing non-addicting painkillers and novel treatments for the causes of pain, will participate in investor sessions at the H.C. Wainwright 25th Annual Global Investment Conference in New York City. JanOne's Chief Medical Officer, Dr. Amol Soin, will appear via recorded video and attend the conference in person to represent the company's mission and progress. Dr. Soin's virtual presentation will be shown September 11 — 13th and will be accessible on the JanOne.com website in subsequent days. This week, on August 29, JanOne announced that it had received a US Patent for its use of its novel formulation of low-dose naltrexone, Jan123, to treat chronic pain. Tony Isaac, JanOne's CEO, noted that the new patent's broad language—covering methods of using JanOne's formulation of low-dose naltrexone to treat chronic pain—"provides robust and broad coverage and protection, and lengthens the timeline for sales significantly." Also last week, on August 25, Dr. Soin announced that his team had won a prestigious "Best Abstract" award for reporting that JanOne's treatment for diabetic neuropathy showed both effectiveness against pain and potential to improve nerve function. The abstract, which was presented at the annual meeting of the Ohio Society of Interventional Pain Physicians (OHSIPP), one of the nation's largest regional pain management meetings, analyzed prior data on Jan101's randomized double blind placebo-controlled trial in diabetic neuropathy patients. About JanOne Inc. JanOne is a unique Nasdaq-listed company offering innovative, actionable solutions intended to help end the opioid crisis. JanOne is dedicated to funding resources toward innovation, technology, and education to find a key resolution to the national opioid epidemic, which is one of the deadliest and most widespread in the nation's history. Its drugs in the clinical trial pipeline have shown promise for their innovative targeting of the causes of pain as a strategic option for physicians averse to exposing patients to addictive opioids. Please visit for additional information. Forward Looking Statements This press release contains statements that are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to the statements that JAN 101 will treat PAD, that JAN 123 will treat CRPS, the timing of the commencement of clinical trials, that the FDA will permit approval through a 505(b)(2) pathway for JAN 123, that upon approval JAN 101 will immediately disrupt the PAD market, and other statements, including words such as "continue", "expect", "intend", "will", "hope" "should", "would", "may", "potential" and other similar expressions. Such statements reflect JanOne's current view with respect to future events, are subject to risks and uncertainties, and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by JanOne, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause JanOne's actual results, performance or achievements to be materially different from any future results, performance or achievements described in this press release. Such factors could include, among others, those detailed in the Company's periodic reports filed with the Securities and Exchange Commission (the "SEC"). Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled "Risk Factors" in JanOne's filings with the SEC underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and JanOne does not intend, and does not assume any obligation, to update these forward-looking statements, except as required by law. JanOne cannot assure that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Individuals are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein. Media Contact Investor Relations IR@janone.com 1-800-400-2247 Company Codes: NASDAQ-NMS:JAN

29 Aug 2023

·www.prnewswire.com

JanOne Earns US Patent for the Use of its Novel Formulation of Low-Dose Naltrexone, Jan123, to Treat Chronic Pain

The Broad Patent Coverage is a Major Milestone for the Commercial Success of Jan123 LAS VEGAS, Aug. 29, 2023 /PRNewswire/ -- JanOne (Nasdaq: JAN), the visionary biotech company dedicated to discovering non-addictive treatments for pain, as well as causes of pain, has earned a US patent for its innovative formulation of low-dose naltrexone, Jan123, for treating pain. Continue Reading Jan123 is being developed to treat complex regional pain syndrome (CRPS), a rare and often life-altering condition characterized by severe pain and hypersensitivity to touch. Tony Isaac, JanOne's CEO, said that the broad language of the new patent—covering methods of using our formulation of low-dose naltrexone to treat chronic pain — provides robust and broad coverage and protection, and lengthens the timeline for sales significantly. The Broad Patent Coverage is a Major Milestone for the Commercial Success of Jan123 Tweet this "Today, patients with complex regional pain syndrome must resort to long-term opioid and narcotics for relief," Isaac said. "If Jan123 is approved, sufferers of CRPS will finally have proven, non-addictive relief." Low-dose naltrexone has been shown in multiple studies and case reports to provide symptom relief in patients who suffer from CPRS, an orphan disease with no current FDA approved treatments. "This allowance from the US Patent Office speaks to the novelty of our approach, as well as the inventive spirit of JanOne's scientific team," said Dr. Tony Giordano, the company's Chief Scientific Officer. "Our low-dose naltrexone has the potential to help patients who are suffering from CRPS, and we look forward to testing it in large-scale human trials." Dr. Amol Soin, the inventor of Jan123 and its novel uses, expressed great satisfaction with the US Patent Office's action. "This patent will allow us to help many patients who struggle with CRPS and is a validation of years of hard work by our team." In citing features of the drug's formulation, the new patent explains Jan123's mechanism of action, including that "it increases endogenous enkephalins and endorphins which are the body's natural pain killers," resulting in a decrease in patient pain. The full benefits of Jan123 may not yet to be known, but as stated in the patent: "Not only does low-dose naltrexone treat the pain symptom of CRPS, but it can also treat the disease process and disease cascades… It may actually treat the underlying disease state, which would be extremely beneficial to the patient." "All in all," CEO Isaac concluded, "this patent approval is an important milestone in our company's brief history—and a welcome confirmation of our strategic vision." About JanOne Inc. JanOne is a unique Nasdaq-listed company offering innovative, actionable solutions intended to help end the opioid crisis. JanOne is dedicated to funding resources toward innovation, technology, and education to find a key resolution to the national opioid epidemic, which is one of the deadliest and most widespread in the nation's history. Its drugs in the clinical trial pipeline have shown promise for their innovative targeting of the causes of pain as a strategic option for physicians averse to exposing patients to addictive opioids. Forward Looking Statements This press release contains statements that are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to the statements that JAN 101 will treat PAD, that JAN 123 will treat CRPS, the timing of the commencement of clinical trials, that the FDA will permit approval through a 505(b)(2) pathway for JAN 123, that upon approval JAN 101 will immediately disrupt the PAD market, and other statements, including words such as "continue", "expect", "intend", "will", "hope" "should", "would", "may", "potential" and other similar expressions. Such statements reflect JanOne's current view with respect to future events, are subject to risks and uncertainties, and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by JanOne, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause JanOne's actual results, performance or achievements to be materially different from any future results, performance or achievements described in this press release. Such factors could include, among others, those detailed in the Company's periodic reports filed with the Securities and Exchange Commission (the "SEC"). Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled "Risk Factors" in JanOne's filings with the SEC underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and JanOne does not intend, and does not assume any obligation, to update these forward-looking statements, except as required by law. JanOne cannot assure that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Individuals are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein. Please visit for additional information. Media Contact Investor Relations [email protected] 1-800-400-2247 SOURCE JanOne Inc.

Patent Expiration

100 Deals associated with Sodium nitrite

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10 top approved records.

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Indication	Country/Location	Organization	Date
Poisoning	US	Hope Pharmaceuticals, Inc.	14 Feb 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lung Diseases	Phase 2	US	Hope Pharmaceuticals, Inc.	15 Sep 2020
Peripheral Vascular Diseases	Phase 2	US	ALT5 Sigma Corp.	23 Jul 2020
COVID-19	Phase 2	US	Hope Pharmaceuticals, Inc.	22 Jul 2020
Lung Injury	Phase 2	US	Hope Pharmaceuticals, Inc.	22 Jul 2020
Respiratory Distress Syndrome, Acute	Phase 2	US	Hope Pharmaceuticals, Inc.	22 Jul 2020
Respiratory Failure	Phase 2	US	Hope Pharmaceuticals, Inc.	22 Jul 2020
Pulmonary Arterial Hypertension	Phase 2	US	Aires Pharmaceuticals, Inc.	01 Nov 2012
Pulmonary Arterial Hypertension	Phase 2	AU	Aires Pharmaceuticals, Inc.	01 Nov 2012
Pulmonary Arterial Hypertension	Phase 2	HU	Aires Pharmaceuticals, Inc.	01 Nov 2012
Pain, Postoperative	Phase 1	-	The University of Alabama at Birmingham	01 Nov 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02713126 (INABLE \| INABLE-Training Trial \| RELAX, NCT00763867; Nitrate's Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction, NCT02053493; Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF, NCT02742129; Inorganic Nitrite to Enhance Benefits From Exercise Training in Heart Failure With Preserved Ejection Fraction [HFpEF], NCT02713126, CTgov)	Phase 2	Heart failure with normal ejection fraction	92	Cardiac Exercise Training (Placebo)	ltlxaxpmwr(oaequvhnpv) = xrxqeqxefp zswvvlifir (zwsewsmarh, fpscmndgbv - qxkntbvaku) View more	-	26 Apr 2023
				Cardiac Exercise Training+Sodium Nitrite (Sodium Nitrite)	ltlxaxpmwr(oaequvhnpv) = teqwtquqbp zswvvlifir (zwsewsmarh, bltqtdytaa - iqmsflyhvg) View more
ESC2018	Not Applicable	ST Elevation Myocardial Infarction	-	Sodium nitrite therapy	ifqwljrxmy(fwxabqpzkr) = sspunfjwwt hhlznblnzw (qdknqepghf )	Positive	26 Aug 2018
				Sodium nitrite	ifqwljrxmy(fwxabqpzkr) = ekgyjxplen hhlznblnzw (qdknqepghf )
Pubmed \| Am J Cardiol	Phase 1	Out-Of-Hospital Cardiac Arrest	120	25 mg sodium nitrite	oatgrovkot(ymcaeznqxo) = fcreygobmg uqtmiachyh (wwnzrnfcvk ) View more	-	15 Aug 2018
				60 mg sodium nitrite	oatgrovkot(ymcaeznqxo) = dfakcxjtqn uqtmiachyh (wwnzrnfcvk ) View more
ASN2015	Not Applicable	-	12	Placebo (isotonic NaCl)	lbpyieokuz(ptetsqdqvk) = rzgykhoukk nxisuchynw (wxnnikvjvm, 0.02 - 0.47)	Positive	03 Nov 2015
				Sodium nitrite 40 mg/kg/hour	lbpyieokuz(ptetsqdqvk) = knzuuxtahu nxisuchynw (wxnnikvjvm, -0.12 to 0.59)
FP005 (ERA2015)	Not Applicable	-	12	Placebo (isotonic NaCl)	pfyopoevwr(xlawgqryzg) = kjknmmrelu lmmqtlonaw (qhszpmfrcb, 0.02 - 0.47)	Positive	21 May 2015
				Sodium nitrite 40 μg/kg/hour	pfyopoevwr(xlawgqryzg) = irxarubreo lmmqtlonaw (qhszpmfrcb, -0.12 to 0.59) View more
ERS2013	Phase 1	Pulmonary Arterial Hypertension nitric oxide	-	Inhaled AIR001 (Sodium nitrite)	mavjckpygl(nxycfvnqgy) = btxvapepfm byycoywmwk (suadojzuax ) View more	Positive	01 Sep 2013

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